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Clinical trial

Effect of Postoperative Oral Carbohydrate Administration in Total Knee Arthroplasty Elderly Patients

ID
Name
Nanjing First Hospital Han Liu
Description
To evaluate the effects of early oral carbohydrates after TKA on nutritional status, comfort and safety in elderly patients.
Trial arms
Trial start
2022-11-22
Estimated PCD
2023-06-01
Trial end
2023-06-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
100ml carbohydrate containing 12.5g maltodextrin, fructose and glucose
Drank 10.5% of 5 ml/kg body weight (100ml containing 12.5g maltodextrin, fructose and glucose) after extubation in the resuscitation room.
Arms:
EOF group：early carbohydrate feeding
Routine feeding
Patients in group C were observed with 60min of abnormal vital signs after extubation, and returned to the ward for fasting and fasting for at least 6 h, and began to eat gradually through the mouth after anal exhaust
Arms:
Control group：conventional feeding
Size
64
Primary endpoint
Pre-albumin levels at fasting
1 day after surgery
Eligibility criteria
Inclusion Criteria: * Patients undergoing elective knee replacement surgery. * The patient gave informed consent. * Age ≥65 years, Sex is not limited * American Society of Anesthesiologists (ASA)Ⅰ\~Ⅲ level * Body Mass Index (BMI)18\~28kg/m2 Exclusion Criteria: * Preoperative gastric emptying disorders, such as gastroesophageal reflux or previous surgery. * Diabetes mellitus, severe renal insufficiency, or other severe metabolic diseases. * History of motion sickness. * Mental disorders, alcoholism, or a history of substance abuse. * Patients with abnormal swallowing function. * Maltodextrin, fructose allergy or intolerance. * Surgery time was greater than 3 hours.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 64, 'type': 'ESTIMATED'}}
Updated at
2023-05-01

1 organization

1 product

4 indications

Organization
Nanjing First Hospital
Product
Carbohydrate Solution
Indication
Knee Replacement
Indication
Postoperative Oral Carbohydrates
Indication
Postoperative Recovery
Indication
Elderly Patients